MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. PATIENT CONNECTOR CLIP (NON-STERILE); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 04-9100-1

Device Problem Fluid/Blood Leak (1250)

Patient Problems Congestive Heart Failure (1783); Death (1802); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 12/02/2019

Event Type  Death  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing the combi set, true flow bloodline, hemaclip and the adverse events of blood loss, loss of consciousness decompensating chf and death.The cause of the combi set-true flow bloodline and hemaclip¿s separation from the patient¿s cvc is unknown; therefore, causality cannot be established.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Cardiac disease accounts for approximately 45% of all mortality in the esrd population.Based on the totality of the information available, the combi set-true flow bloodline and hemaclip cannot be excluded from having a possible causal or contributory role in the serious adverse events and subsequent death.The patient was actively in treatment when the combi set-true flow bloodline and hemaclip separated from the patient¿s cvc, and the manufacturer¿s investigation of the suspect products is pending.Therefore, there is insufficient evidence to disassociate the combi set-true flow bloodline and hemaclip from the events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) expired.The patient¿s venous bloodline and patient connector clip separated from the hd catheter¿s (not a fresenius product) arterial lumen, resulting in blood loss to the patient.On (b)(6) 2019, the patient arrived at the outpatient dialysis clinic for their regularly scheduled hemodialysis (hd) treatment.The patient¿s pre-treatment vital signs were as follows; blood pressure (bp) ¿ 113/71, heart rate (hr) ¿ 71 beats per min (bpm), temperature (temp) ¿ 95.0, respirations (rr) ¿ 18 and weight ¿ (b)(6) (4.0 kg above estimated dry weight).The patient was alert and oriented and denied any pain, shortness of breath (dyspnea), nausea, vomiting or diarrhea.All pre-treatment machine checks were performed and verified without issue.The hd treatment was initiated at 13:34 via a right central venous catheter (cvc).The patient¿s bp was 117/73 with a hr of 70 bpm, and they received 2.0 liters of oxygen via nasal cannula as ordered.At 14:06, the patient¿s blood flow rate (bfr) was 350 ml/min, with a bp of 96/65 and a hr of 67 bpm.At 14:24 the blood lines were reversed (rationale not provided), and the venous bloodline was connected to the arterial lumen of the cvc (hemaclip applied), and the arterial bloodline was connected to the venous lumen of the cvc.At 14:40, the hd machine¿s venous pressure alarmed and upon inspection the patient¿s venous bloodline (and hemaclip) had disconnected from the patient's arterial lumen of the cvc.Blood could be visualized on the floor (estimated loss > 100 ml).Upon discovery the arterial cvc lumen was reconnected to the venous bloodline and the patient¿s blood was returned.The patient was noted to be gasping for air and became unresponsive (timeline not provided).911 was contacted and cardiopulmonary resuscitative (cpr) measures were initiated.The patient received a total of 1 liter of normal saline, an automated external defibrillator (aed) was applied and a ¿back board¿ was placed behind the patient.The patient was being oxygenated via an ambu bag; however, no hr or rr were noted, and the patient was pronounced dead at approximately 15:30.The patient¿s death certificate reported the patient passed away due to natural causes.The primary cause of death was systolic congestive heart failure (chf) decompensated, and the patient¿s secondary causes of death were diabetes mellitus type ii and stage 5 ckd.

Event Description

It was reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) expired.The patient¿s venous bloodline and patient connector clip separated from the hd catheter¿s (not a fresenius product) arterial lumen, resulting in blood loss to the patient.On (b)(6) 2019, the patient arrived at the outpatient dialysis clinic for their regularly scheduled hemodialysis (hd) treatment.The patient¿s pre-treatment vital signs were as follows; blood pressure (bp) ¿ 113/71, heart rate (hr) ¿ 71 beats per min (bpm), temperature (temp) ¿ 95.0, respirations (rr) ¿ 18 and weight ¿ 75.0 kg (4.0 kg above estimated dry weight).The patient was alert and oriented and denied any pain, shortness of breath (dyspnea), nausea, vomiting or diarrhea.There was no report of visible damage to the products, and all pre-treatment machine checks were performed without issue.The hd treatment was initiated at 13:34 via a right central venous catheter (cvc).The patient¿s bp was 117/73 with a hr of 70 bpm, and they received 2.0 liters of oxygen via nasal cannula as ordered.At 14:06, the patient¿s blood flow rate (bfr) was 350 ml/min, with a bp of 96/65 and a hr of 67 bpm.At 14:24 the blood lines were reversed in an attempt to improve the patient¿s blood flow rate (bfr), and the venous bloodline was connected to the arterial lumen of the cvc (hemaclip applied), and the arterial bloodline was connected to the venous lumen of the cvc.The required safety check, validation and documentation of the hd catheter lumen reversal and hemaclip checks were performed at 14:25.At 14:40, the hd machine¿s venous pressure alarmed and upon inspection the patient¿s venous bloodline (and hemaclip) had disconnected from the patient's arterial lumen of the cvc.Blood could be visualized on the floor (estimated loss > 100 ml).Upon discovery the arterial cvc lumen was reconnected to the venous bloodline and the patient¿s blood was returned.The patient was noted to be gasping for air and became unresponsive (timeline not provided).911 was contacted and cardiopulmonary resuscitative (cpr) measures were initiated.The patient received a total of 1 liter of normal saline, an automated external defibrillator (aed) was applied and a ¿back board¿ was placed behind the patient.The patient was being oxygenated via an ambu bag; however, no hr or rr were noted, and the patient was pronounced dead at approximately 15:30.The patient¿s death certificate reported the patient passed away due to natural causes.The primary cause of death was systolic congestive heart failure (chf) decompensated, and the patient¿s secondary causes of death were diabetes mellitus type ii and stage 5 ckd.

Manufacturer Narrative

Additional information: additional information was obtained through follow up with clinic manager.B5 has been updated with the new information obtained, and the clinical review has been updated.Clinical review: a temporal relationship exists between hd therapy utilizing the combi set, true flow bloodline, hemaclip and the adverse events of blood loss, loss of consciousness decompensating chf and death.The cause of the combi set-true flow bloodline and hemaclip¿s separation from the patient¿s cvc is unknown; therefore, causality cannot be established.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Cardiac disease accounts for approximately 45% of all mortality in the esrd population.Based on the totality of the information available, the combi set-true flow bloodline and hemaclip cannot be excluded from having a possible causal or contributory role in the serious adverse events and subsequent death.The patient was actively undergoing hd therapy when the combi set-true flow bloodline and hemaclip separated from the patient¿s cvc, and the combi set-true flow bloodline (hemaclip was discarded) has not been received by the manufacturer for evaluation.Therefore, there is insufficient evidence to disassociate the combi set-true flow bloodline and hemaclip from the events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius patient connector clips shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.In addition the instruction for use was reviewed and was found that it contains steps for the connection of the product.The instruction for use that is included in the packaging of the product explained in a detailed manner the connection and disconnection steps and includes pictures as visual aids.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: PATIENT CONNECTOR CLIP (NON-STERILE)
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9526527
• MDR Text Key: 172914804
• Report Number: 8030665-2019-01952
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100828
• UDI-Public: 00840861100828
• Combination Product (y/n): N
• PMA/PMN Number: K001873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04-9100-1
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71